BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERMETIC LUMBAR CATHETER, CLOSED TIP

    MDR report key: 1675899 · Received April 23, 2010

    Report

    Report Number
    2648988-2010-00028
    Event Type
    Malfunction
    Date Received
    April 23, 2010
    Report Date
    April 23, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTING FACILITY DESCRIBED A PT EVENT DURING THE USE ON AN INS-5010-HERMATIC LUMBAR CATHETER CLOSED TIP. THE CATHETER BUNCHED WHILE REMOVING THE GUIDE WIRE. UPON REMOVAL, IT WAS NOTED THE CATHETER WAS RIPPED. THE CATHETER WAS REMOVED. A SECOND ATTEMPT WAS MADE USING A SECOND INS-5010 WITH SIMILAR RESULT. THE PROCEDURE AS SUCCESSFULLY COMPLETED USING AN ALTERNATE DEVICE IN COMBINATION WITH THE LIMITORR. NO PT INJURY OCCURRED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERMETIC LUMBAR CATHETER, CLOSED TIP NA JXG INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other